Speaker Profile

Alan M Golden
Alan M Golden
Principal,

Alan M Golden has over 35 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 20 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.

Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.

Upcoming Webinars Recorded Webinars
  • 23
  • January
  • 2025
  • Thursday
10:00 AM PST | 01:00 PM EST

Design Control for Medical Devices: Overview and Design Inputs

Verification and validation of design inputs is a critical step in the development of medical devices.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
  • 28
  • January
  • 2025
  • Tuesday
10:00 AM PST | 01:00 PM EST

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
  • 31
  • January
  • 2025
  • Friday
10:00 AM PST | 01:00 PM EST

How to Prepare for and Conduct a Regulatory Audit

In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
  • 4
  • February
  • 2025
  • Tuesday
10:00 AM PST | 01:00 PM EST

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
  • 11
  • February
  • 2025
  • Tuesday
10:00 AM PST | 01:00 PM EST

Impact Assessment and Risk Management for Change Control

In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
  • 17
  • February
  • 2025
  • Monday
10:00 AM PST | 01:00 PM EST

Assess Impact for Supplier Change Notices

This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
  • 21
  • February
  • 2025
  • Friday
10:00 AM PST | 01:00 PM EST

Design Control for Medical Devices: Overview and Design Inputs

Verification and validation of design inputs is a critical step in the development of medical devices.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
  • 24
  • February
  • 2025
  • Monday
10:00 AM PST | 01:00 PM EST

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
  • 26
  • February
  • 2025
  • Wednesday
10:00 AM PST | 01:00 PM EST

How to Prepare for and Conduct a Regulatory Audit

In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.

Alan M Golden Alan M Golden | Duration:60 Minutes | Price: $150.00 | View Details
Alan M Golden

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Impact Assessment and Risk Management for Change Control

In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control. We will discuss how to determine the level of impact assessment needed for what type of changes and how to base this decision on risk.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Impact Assessment and Risk Management for Change Control

In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Design Control for Medical Devices: Overview and Design Inputs

Verification and validation of design inputs is a critical step in the development of medical devices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

How to Prepare for and Conduct a Regulatory Audit

In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Alan M Golden | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Alan M Golden

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Impact Assessment and Risk Management for Change Control

In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Assess Impact for Supplier Change Notices

This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Design Control for Medical Devices: Overview and Design Inputs

Verification and validation of design inputs is a critical step in the development of medical devices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

How to Prepare for and Conduct a Regulatory Audit

In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Alan M Golden

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Impact Assessment and Risk Management for Change Control

In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control. We will discuss how to determine the level of impact assessment needed for what type of changes and how to base this decision on risk.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Impact Assessment and Risk Management for Change Control

In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

How to Prepare for and Conduct a Regulatory Audit

In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Alan M Golden | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Alan M Golden

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Impact Assessment and Risk Management for Change Control

In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Assess Impact for Supplier Change Notices

This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Design Control for Medical Devices: Overview and Design Inputs

Verification and validation of design inputs is a critical step in the development of medical devices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Alan M Golden

How to Prepare for and Conduct a Regulatory Audit

In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.

Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details